MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00917741

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pump and the hl unit have been removed from service.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

As stated by the customer: "after 30mins of bypass, the arterial pump stopped working, sounding a continuous high pitched alarm and displaying "safety-s" error on the roller pump display.Perfusionists resorted to hand cranking.Two attempts to reboot the specific pump did not restore its function, with "runaway" error displayed.Hand cranking continued for another 15 mins until the end of bypass." no harm of the patient has been reported.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).During investigation at pharma - cos limited laboratory a defective optical tacho has been found.After replacement and calibration of the optical tacho the pump is now in normal operating conditions.Thus the failure could be confirmed.2018-05-30: as confirmed by the field service technician, the replaced parts have been already scrapped.They are no longer available for return.Further investigation not possible.Most probable root cause could not be determined.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Internal reference: (b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7349595
• MDR Text Key: 102894811
• Report Number: 8010762-2018-00097
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00917741
• Device Catalogue Number: 70102850
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1